GSK's obesity drug gets OTC approval

GSK's anti obesity drug, alli, has been approved for use without a prescription by the EC

GlaxoSmithKline's (GSK) anti obesity drug, alli, has been approved for use without a prescription by the European Commission (EC).

The approval is a first by the EC for a non-prescription or over-the-counter (OTC) product for weight loss. GSK has approval to introduce alli in all 27 EU member states, and Norway. The weight loss drug will be available to adults with a BMI of 28 or higher.

Leading European obesity expert, Professor Stephan Jacob from the Cardio-Metabolic Institute in Germany, said: "Research has shown that consumers are spending millions of Euros each year on fad diets, unproven 'miracle pills' and potentially unsafe weight-loss supplements, often without any scientific evidence to back them up. By making a licensed non-prescription product available, consumers will have the option of a proven therapy, which can support them with their struggle against weight loss. For many, losing weight can become the catalyst to improvements in their overall health and self-esteem."

Clinical trials have shown that when used in conjunction with a reduced calorie, lower-fat diet, alli can help people lose 50 per cent more weight than by dieting alone. Orlistat, the active ingredient in alli, has been available as a prescription-only treatment in a higher dosage of 120mg for the past 10 years.

Alli has been available in the US since June 2007 where, according to GSK, it has helped millions of people to lose weight and adopt a healthy lifestyle. As in Europe, alli is the only weight-loss drug approved by the US Food and Drug Administration (FDA) that is available without a prescription.